Fast-Moving Bill in Congress Would Weaken FDA Oversight of New Drugs and Devices

Congress is moving quickly to pass a bill that would authorize higher industry fees for the FDA in exchange for speeding up the approval of some drugs and medical devices and eliminating restrictions on financial conflicts of interest among the agency’s advisory scientists.

Consumer groups oppose the bill, saying it would weaken FDA oversight of new drugs and medical devices, allowing more drugs and devices on the market without adequate testing of their safety and effectiveness. It would also eliminate a restriction on the FDA’s use of advisory scientists with financial conflicts of interest, which had been imposed in the last FDA user-fee authorization bill Congress passed in 2007.

The Senate could pass the bill as early as next week, says Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, one of the consumer groups objecting to the bill, which made it through the House Energy and Commerce Committee last week.

The bill, as Public Citizen argues here, gives companies working on drugs for life-threatening conditions an easier pathway to approval by allowing them to use smaller studies and postpone definitive clinical trials proving effectiveness until after the drug hits the market. Instead of being required to use end points that show the drugs are effective against the actual disease, the drug companies are allowed to use surrogate end points or markers and much smaller clinical trials to gain FDA approval. Carome argues that this will only increase the number of unsafe and ineffective drugs on the market.

The bill also eliminates a new clinical trial requirement for medical devices that are considered “follow-on” devices. Yet this requirement was imposed precisely because, as gooznews reports, the industry has been plagued in recent years by the recalls of follow-on devices such as metal-on-metal artificial hips and implanted cardio-defibrillators.

Carome tells gooznews that the industry heavily lobbied both sides of Congress to get provisions favorable to industry inserted into the new user-fee bill. And indeed both the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association, which represents medical device companies, praised the bill in press releases last week.

What all of this reminds me of is the banking industry, which was busy lobbying the feds to weaken restrictions on risky trading activities even as JP Morgan Chase dove off the cliff with a risky bet on credit derivatives and lost at least $2 billion.

What’s at stake here is not just our money (JP Morgan was gambling with its own customers’ money), but the health and well-being of American citizens. Do we have to wait for another drug-related debacle (think Vioxx or Avandia or antidepressants that caused hundreds of suicides), before Congress wakes up and stops weakening the FDA’s ability to protect us?

A former medical and science writer for TheBoston Globe, Alison Bass writes about conflicts of interest in medicine and flaws in the way drugs are tested and marketed. She is a Pulitzer Prize nominee and author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial.

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The FDA, along with all the other US regulatory agencies, are complete jokes and lull the public into a false sense of security. It is hard to imagine the FDA being more lax in their oversight of drugs and medical devices. @ John Hogget this is not regular capitalism, this is corporate capitalism/fascism. And it is only going to get worse.

A little followup quote by Aldous Huxley made in 1961: “There will be, in the next generation or so, a pharmacological method of making people love their servitude, and producing dictatorship without tears, so to speak, producing a kind of painless concentration camp for entire societies, so that people will in fact have their liberties taken away from them, but will rather enjoy it, because they will be distracted from any desire to rebel by propaganda or brainwashing, or brainwashing enhanced by pharmacological methods. And this seems to be the final revolution.” Aldous Huxley